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云顶新耀(01952):维适平®用于治疗成人患者中重度溃疡性结肠炎的新药上市申请在中国获批
智通财经网· 2026-02-06 04:14
在全球化能力建设方面,公司启动全球化战略,推进全球化的注册及临床开发能力建设。到2030年,本 公司计划透过"海外授权+商业化"的双引擎驱动增长,加快国际化发展步伐。 2030年发展战略标志着本公司迈向全球生物制药前沿的重要里程碑。未来五年,公司将聚焦"BD合作 +自研"双轮驱动,依托科学与市场洞察,推动战略领域形成 N+X产品组合,把握蓝海大单品机遇。本 公司计划通过已经建立的商业拓展能力,每年引进3至5个中后期重磅产品,依托自身精干高效的商业化 团队实现每个产品医保后三年销售达峰。未来五年,公司计划引进20个以上的高值资产,为 2030年贡 献收入60亿元人民币,并在2035年实现大约300亿元人民币的收入贡献。 通过此战略布局,本公司致力于在核心治疗领域和创新药研发上持续领先,打造可持续增长的全球化创 新型生物制药企业,致力于成为全球领先的综合性生物制药公司。 此次新药上市申请获批亦是本公司2030年发展战略的重要一部份,此发展战略明确提出以"BD合作+自 研"双轮驱动,实现商业化创造确定性价值、研究与试验发展(研发)创造成长性价值。本公司将持续巩 固核心治疗领域优势,推进创新药研发和商业化,打造可持续 ...
云顶新耀(01952) - 自愿公告最新业务情况有关维适平用於治疗成人患者中重度溃疡性结肠炎的新药上...
2026-02-06 04:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或 完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因倚賴該 等內容而引致的任何損失承擔任何責任。 (於開曼群島註冊成立的有限公司) (股份代號:1952) Everest Medicines Limited 雲 頂 新 耀 有 限 公 司 自願公告 最新業務情況 有關維適平®用於治療成人患者中重度潰瘍性結腸炎的 新藥上市申請在中國獲批及其他企業最新動態 本公告由雲頂新耀有限公司(「本公司」)自願作出,以向本公司股東及潛在投資者 提供有關最新業務資料。 本 公 司 董 事 會(「董 事 會」)欣 然 宣 佈 , 中 國 國 家 藥 品 監 督 管 理 局 (NMPA) 已 批 准 維 適平®( 精氨酸艾曲莫德片, VELSIPITY ® )的新藥上市申請(「新藥上市申請」),在 中國用於治療對傳統治療或生物製劑應答不充分、失應答或不耐受的中度至重度 活動性潰瘍性結腸炎(「UC」)成人患者。 作為新一代高選擇性鞘氨醇-1 -磷酸(S1P)受體調節劑,維適平®每日一次口服,可 實現快速起效和強效深度黏膜癒 ...
港股公告掘金 | 美团-W拟收购Dingdong Fresh Holding Limited全部已发行股份
Zhi Tong Cai Jing· 2026-02-05 15:17
Major Events - Genting New Year (01952) subsidiary signed an agreement with Macao to commercialize MT1013 in Greater China and other Asian markets [1] - Junshi Biosciences (02696) entered into a licensing agreement with Eisai for Hansizhuang® to treat tumor indications [1] - Meituan-W (03690) plans to acquire all issued shares of Dingdong Fresh Holding Limited [1] - China Power (02380) subsidiary Xinyuan Zhichu signed a procurement contract for BESS with Tori [1] - Aimee Vaccine (06660) successfully passed the registration site inspection for its globally self-researched serum-free rabies vaccine [1] Operating Performance - NIO-SW (09866) issued a profit warning, expecting adjusted operating profit of 700 million to 1.2 billion yuan in Q4 2025, turning from loss to profit year-on-year [1] - Saint Bella (02508) issued a profit warning, expecting adjusted net profit of no less than 120 million yuan for 2025, a year-on-year increase of no less than 183% [1] - Geek+ (02590) achieved orders of 4.137 billion yuan in 2025, a year-on-year growth of approximately 31.7% [1] - China Overseas Development (00688) achieved contract property sales of approximately 14.478 billion yuan in January, a year-on-year increase of 20.4% [1] - Swire Properties (01972) reported a rental rate of 96% for Swire Plaza in Q4, with rents down by 13% [1] - Greentown China (03900) reported total contract sales of approximately 9.7 billion yuan in January, a year-on-year decrease of 14.16% [1]
肾病领域双靶点多肽药物MT1013达成独家商业化合作
Xin Lang Cai Jing· 2026-02-05 12:24
Core Viewpoint - The strategic partnership between Macao and Yunding Xinyao grants the latter exclusive commercialization rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan), marking a significant step in the company's global expansion and realization of innovative drug value [1][6]. Group 1: Strategic Partnership - Macao has officially announced a strategic collaboration with Yunding Xinyao, granting exclusive commercialization rights for MT1013 [1][6]. - The agreement includes an upfront payment of 200 million RMB and potential milestone payments up to 1.04 billion RMB, indicating a strong financial incentive for both parties [1][6]. Group 2: Drug Innovation and Mechanism - MT1013 is a first-in-class peptide drug developed by Macao, targeting both calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP) pathways, representing a shift from passive bone resorption inhibition to active bone formation promotion [2][7]. - The drug aims to comprehensively regulate PTH secretion, correct calcium and phosphorus metabolism, and directly enhance bone health [2][7]. Group 3: Clinical Data and Efficacy - Key Phase II clinical trial data for MT1013 demonstrate significant efficacy and therapeutic potential, with a Phase III registration trial currently underway for SHPT patients undergoing maintenance hemodialysis [4][10]. - MT1013 shows superior performance in achieving triple targets of iPTH, blood calcium, and blood phosphorus levels, along with excellent phosphorus-lowering effects and a significant reduction in cardiovascular risk marker FGF-23 [8][10]. - After 52 weeks of treatment, patients exhibited significant improvements in bone density and sustained enhancements in bone metabolism markers [8][10].
肾科战略布局升级 云顶新耀引进全球首创双靶点新药
Huan Qiu Wang Zi Xun· 2026-02-05 09:00
Group 1 - The core viewpoint of the news is that CloudTop New Medicine has signed an exclusive commercialization license agreement with Macao to obtain global rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan) [1][2] - CloudTop will pay Macao a signing fee of 200 million RMB and potential regulatory and commercial milestone payments of up to 1.04 billion RMB [1] - The collaboration is a strategic move for CloudTop to enhance its innovative pipeline and expand its treatment capabilities in nephrology, creating a strong synergistic effect with its existing nephrology pipeline [1][2] Group 2 - The chairman of CloudTop, Wu Yifang, emphasized the significant unmet clinical needs in secondary hyperparathyroidism (SHPT) against the backdrop of a rising number of chronic kidney disease patients globally [2] - MT1013 is expected to provide a new treatment option for SHPT patients, positioning it as a potential best-in-class drug that will synergize with the company's existing nephrology product portfolio [2] - The partnership marks a shift in CloudTop's nephrology strategy from focusing on a single disease to a more systematic and platform-based approach, aiming to expand into broader treatment areas such as glomerulonephritis and chronic kidney disease and its complications [2]
云顶新耀(01952) - 截至二零二六年一月三十一日止月份之股份发行人的证券变动月报表
2026-02-05 08:39
| 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01952 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致:香港交易及結算所有限公司 公司名稱: 雲頂新耀有限公司 呈交日期: 2026年2月5日 I. 法定/註冊股本變動 本月底法定/註冊股本總額: USD 50,000 FF301 第 1 ...
港股云顶新耀涨超4%
Mei Ri Jing Ji Xin Wen· 2026-02-05 07:36
每经AI快讯,云顶新耀(01952.HK)涨超4%,截至发稿涨4.03%,报39.22港元,成交额8486.66万港元。 (文章来源:每日经济新闻) ...
港股异动 | 云顶新耀(01952)涨超4% 引进全球首创双靶点多肽新药MT1013
智通财经网· 2026-02-05 07:20
另一方面,通过引入MT1013这一临床后期创新资产,云顶新耀也将进一步丰富肾科管线梯队,构建起 兼具短期收益、中期增长与长期潜力的可持续管线体系。根据协议,云顶新耀将向麦科奥特支付人民币 2亿元首付款,以及最高不超过人民币10.40亿元的潜在监管及商业里程碑付款。目前,MT1013中国III 期临床研究正在进行中,相关临床开发费用将由麦科奥特承担。 智通财经APP获悉,云顶新耀(01952)涨超4%,截至发稿,涨4.03%,报39.22港元,成交额8486.66万港 元。 消息面上,2月5日,云顶新耀宣布与麦科奥特签署独家商业化许可协议,获得全球首创双靶点多肽新药 MT1013在中国及亚太区(日本除外)的独家商业化授权。此次合作标志着云顶新耀肾科战略由聚焦单一 疾病领域向系统化和平台化的发展阶段升级,MT1013将与云顶新耀现有肾科管线形成协同效应,强化 产品布局,巩固公司在亚洲肾脏及自身免疫疾病领域的领导地位,并将产品覆盖从IgA肾病拓展至更广 泛的慢性肾脏病领域。 ...
云顶新耀涨超4% 引进全球首创双靶点多肽新药MT1013
Zhi Tong Cai Jing· 2026-02-05 07:18
云顶新耀(01952)涨超4%,截至发稿,涨4.03%,报39.22港元,成交额8486.66万港元。 消息面上,2月5日,云顶新耀宣布与麦科奥特签署独家商业化许可协议,获得全球首创双靶点多肽新药 MT1013在中国及亚太区(日本除外)的独家商业化授权。此次合作标志着云顶新耀肾科战略由聚焦单一 疾病领域向系统化和平台化的发展阶段升级,MT1013将与云顶新耀现有肾科管线形成协同效应,强化 产品布局,巩固公司在亚洲肾脏及自身免疫疾病领域的领导地位,并将产品覆盖从IgA肾病拓展至更广 泛的慢性肾脏病领域。 另一方面,通过引入MT1013这一临床后期创新资产,云顶新耀也将进一步丰富肾科管线梯队,构建起 兼具短期收益、中期增长与长期潜力的可持续管线体系。根据协议,云顶新耀将向麦科奥特支付人民币 2亿元首付款,以及最高不超过人民币10.40亿元的潜在监管及商业里程碑付款。目前,MT1013中国III 期临床研究正在进行中,相关临床开发费用将由麦科奥特承担。 ...
云顶新耀肾病领域再布一子 引进多肽新药MT1013
Zheng Quan Ri Bao Wang· 2026-02-05 05:48
此前,云顶新耀已凭借全球首个IgA肾病对因治疗药物耐赋康在肾病治疗领域崭露头角。该公司财务数据显示,2025年前 三季度,耐赋康的销售额突破10亿元。云顶新耀方面表示:"耐赋康的成功,不仅验证了云顶新耀在肾科领域的渠道覆盖与学 术推广能力,更依托于云顶新耀搭建起的以科学和商业洞察为基础的'准入、医学、市场、销售'(A2MS)一体化的商业化运 营平台。MT1013的加入,将与云顶新耀现有的肾科产品组合形成高度协同,推动公司肾科布局从覆盖IgA肾病拓展至更广泛的 慢性肾脏病,进一步完善肾科产品矩阵,夯实其在肾科领域的布局优势。" 对于此次合作,云顶新耀董事会主席吴以芳表示:"在全球慢性肾脏病患者持续增加的背景下,继发性甲状旁腺功能亢进 仍存在显著临床未满足需求。MT1013作为具备全球首创双重作用机制的临床后期创新资产,有望为SHPT患者提供全新的治疗 选择。作为潜在同类最佳药物,MT1013将与公司现有的肾科产品组合形成高度协同,进一步夯实公司在肾科领域的布局。云 顶新耀在持续深耕自身免疫相关肾脏疾病的基础上,正加速拓展至肾小球肾炎以及慢性肾脏病及其并发症等更广泛的治疗领 域。此次合作是公司完善创新管线、拓展肾 ...